Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05295420 |
| Other study ID # |
Ahmed Tahoon |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
July 2023 |
| Source |
Egymedicalpedia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and
lead to depression and social isolation Stress urinary incontinence (SUI) refers to the
involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and
sneezing). It is commonly acquired after pregnancy and childbirth due to the weakening of the
pelvic floor muscles that support the urethra against the anterior vaginal wall.
Current SUI treatment includes surgery to re-establish sufficient urethral resistance in
order to prevent urine leakage during increased intra-abdominal pressure.
Description:
Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and
lead to depression and social isolation.
Stress urinary incontinence (SUI) refers to the involuntary leakage of urine accompanying
physical exertion (i.e. coughing, exercise, and sneezing). It is commonly acquired after
pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the
urethra against the anterior vaginal wall.
Current SUI treatment includes surgery to re-establish sufficient urethral resistance in
order to prevent urine leakage during increased intra-abdominal pressure.
The mid-urethral sling (MUS) has become the preferred procedure, as it is less invasive than
the Burch colposuspension. However, the MUS procedure has a 5-20% failure rate and carries
risks such as infection, voiding dysfunction, hemorrhage, pain, bladder or urethral injury,
and mesh erosion.
Hence, there is a need for alternative efficacious, outpatient SUI treatments.
Platelet-derived therapies are a growing trend across multiple medical and surgical
specialties. Evidence suggests that platelets play an important role in tissue repair,
vascular remodeling and inflammatory and immune responses through secretion of growth
factors, cytokines, and chemokines.
These biologically active proteins include transforming growth factor-β, platelet-derived
growth factor, platelet-derived epithelial growth factor, insulin-like growth factor,
vascular endothelial growth factor. These growth factors are implicated in many aspects of
natural wound healing, including chemotaxis, cell proliferation, cell differentiation. The
key role of platelets in these processes makes them an attractive candidate for therapies
aimed at accelerating natural healing.
One of the most well-described platelet-based therapies is autologous platelet-rich plasma
(PRP). PRP is derived from the centrifugation of whole blood with a separator gel to remove
the red and white blood cells. The resulting supernatant has a greater than four-fold
increase in platelets and other plasma proteins. This concentrate is then administered via
injection.
